U.S. patent number 5,275,173 [Application Number 07/983,478] was granted by the patent office on 1994-01-04 for extendable guidewire assembly.
This patent grant is currently assigned to Target Therapeutics, Inc.. Invention is credited to Steve P. Bernath, Bobbie H. P. Hsi, Gene Samson.
United States Patent |
5,275,173 |
Samson , et al. |
January 4, 1994 |
Extendable guidewire assembly
Abstract
An extendable guidewire assembly comprising: a guidewire having
a tapered proximal end; an extension wire having a tapered distal
end; a first polymeric tubular sleeve that is fixedly attached
about the tapered distal end of the extension wire such that the
tapered distal end of the extension wire extends partly through the
sleeve lumen, said lumen having a diameter that is smaller than the
untapered diameter of the guidewire and wherein said lumen expands
radially when the sleeve is under axial compression and contracts
radially when the sleeve is under axial tension; and a second
polymeric sleeve to guide the guidewire into the first polymeric
sleeve.
Inventors: |
Samson; Gene (Milpitas, CA),
Hsi; Bobbie H. P. (Palo Alto, CA), Bernath; Steve P.
(San Jose, CA) |
Assignee: |
Target Therapeutics, Inc.
(Fremont, CA)
|
Family
ID: |
25018330 |
Appl.
No.: |
07/983,478 |
Filed: |
December 1, 1992 |
Related U.S. Patent Documents
|
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
750558 |
Aug 26, 1991 |
5188621 |
|
|
|
Current U.S.
Class: |
600/585 |
Current CPC
Class: |
A61M
25/0905 (20130101) |
Current International
Class: |
A61M
25/01 (20060101); A61B 005/00 () |
Field of
Search: |
;128/657,772
;604/95,164,166,170,171,175,283,905 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Hindenburg; Max
Attorney, Agent or Firm: Morrison & Foerster
Parent Case Text
CROSS-REFERENCE TO A RELATED APPLICATION
This application is a continuation-in-part of U.S. Pat. No.
07/750,558 filed Aug. 26, 1991, now U.S. Pat. No. 5,188,621 of
which is incorporated herein by reference.
Claims
We claim:
1. An extendable guidewire assembly for use within a patient's
vasculature comprising in combination:
(a) a guidewire having a distal end that is adapted to be fed into
said vasculature and a tapered proximal end;
(b) an extension wire having a proximal end and a tapered distal
end;
(c) a first polymeric sleeve having first and second ends and a
lumen extending therebetween, said first end being fixedly attached
concentrically about one of either the proximal end of the
guidewire or the distal end of the extension wire, such that said
one end extends partly through the lumen of the sleeve, said second
end being adapted to receive the other of the proximal end of the
guidewire or the distal end of the extension wire, said lumen
having a diameter that is smaller than the untapered diameter of
the wire to which the sleeve is not fixedly attached and wherein
said lumen expands radially when the sleeve is under axial
compression during introduction of the guidewire or the extension
wire into the lumen and contracts radially when the sleeve is under
axial tension; and
(d) a second polymeric sleeve having first and second ends and a
lumen extending therebetween, said first end having a smaller
inside diameter than said second end, said first end being
concentric about the first polymeric sleeve, said second end being
adapted to receive the proximal end of the guidewire or the distal
end of the extension wire not fixedly attached to the first
polymeric sleeve, and to guide the guidewire or extension wire into
the proximal end of the first polymeric sleeve.
2. The extendable guidewire assembly of claim 1 wherein the first
polymeric sleeve is fixedly attached about the distal end of the
extension wire.
3. The extendable guidewire assembly of claim 2 wherein the
untapered diameter of the guidewire is about 0.3 to 0.4 mm, the
untapered diameter of the extension wire is about 0.3 to 0.4 mm,
and the diameter of the sleeve lumen is less than said untapered
diameter of the guidewire.
4. The extendable guidewire assembly of claim 3 wherein the length
of the tapered end of the guidewire is 3 to 7 cm, the length of the
tapered end of the extension wire is 3 to 7 cm and the length of
the first polymeric sleeve is 5 to 8 cm and the length of the
second polymeric sleeve is 3.5 to 5 cm.
5. The extendable guidewire assembly of claim 1 wherein the taper
of the proximal end of the guidewire is a conical taper and the
taper of the distal end of the extension wire is a conical
taper.
6. The extendable guidewire assembly of claim 1 wherein said one
end to which the first polymeric sleeve is fixedly attached extends
through greater than half the length of the sleeve lumen.
7. The extendable guidewire assembly of claim 1 wherein the first
polymeric sleeve is made of polyimide and the wall thickness of the
first polymeric sleeve is 0.025 to 0.05 mm.
8. The extendable guidewire assembly of claim 1 wherein the second
polymeric sleeve is made of polyethylene and the wall thickness of
the second polymeric sleeve is 0.10 to 0.13 mm.
9. A kit for use in connecting and disconnecting an extendable
guidewire assembly for use within a patient's vasculature
comprising in combination:
(a) a guidewire having a distal end that is adapted to be fed into
said vasculature and a tapered proximal end;
(b) an extension wire having a proximal end and a tapered distal
end;
(c) a first polymeric sleeve having first and second ends and a
lumen extending therebetween, said first end being fixedly attached
concentrically about one of either the proximal end of the
guidewire or the distal end of the extension wire such that said
one end extends partly through the lumen of the sleeve, said second
end being adapted to receive the other of the proximal end of the
guidewire or the distal end of the extension wire, said lumen
having a diameter that is smaller than the untapered diameter of
the wire to which the sleeve is not fixedly attached and wherein
the lumen expands radially when the sleeve is under axial
compression during introduction of the guidewire or the extension
wire into the lumen and contracts radially when the sleeve is under
axial tension;
(d) a second polymeric sleeve having first and second ends and a
lumen extending therebetween, said first end having a smaller
inside diameter than said second end, said first end being
concentric about the first polymeric sleeve, said second end being
adapted to receive the proximal end of the guidewire or the distal
end of the extension wire, and to guide the guidewire or extension
wire into the proximal end of the first polymeric sleeve; and
(e) a detachment tool having a slot that is dimensioned to receive
the untapered portion of the guidewire, the slot being further
dimensioned such that the outer diameter of the first polymeric
sleeve is larger than the slot.
Description
TECHNICAL FIELD
This invention is in the general field of surgical instruments and
relates specifically to an extendable guidewire assembly that is
used in cardiovascular and endovascular procedures to facilitate
the placement of catheters within the vasculature of patients.
BACKGROUND
The general procedure for placing catheters within vessels is to
track a guidewire through the vessel to the desired position and
advance the catheter over the guidewire. Guidewires are required
because the catheters themselves do not have sufficient column
strength or torqueability to be able to be tracked or steered
through the vessel. See, for instance, U.S. Pat. No. 4,884,579.
In some procedures such as angioplasty using dilatation balloon
catheters, it is necessary to exchange catheters to increase
balloon size. It may also be necessary in some instances to replace
catheters due to material fatigue. Two guidewire techniques have
been employed in such instances. In one, the initial guidewire is
removed and replaced with an exchange wire that is somewhat greater
than double the length of the catheter. In order to avoid the need
for a separate exchange wire a second technique that involves
attaching an extension wire to the initial guidewire was
developed.
U.S. Pat. Nos. 4,917,103 and 4,922,923 describe an extendable
guidewire assembly that employs a sleeve that is connected to the
proximal end of the guidewire and into which the distal end of the
extension wire is inserted. The sleeve and extension are then
crimped to form a permanent joint or union between the two
wires.
U.S. 4,875,489 describes another type of extendable guidewire
assembly in which one of the wires has a tapered tip and the other
has an expandable sleeve into which the tip is received. A second
concentric sleeve encloses the expandable sleeve to ensure a
friction fit between the tapered tip and expandable sleeve.
U.S. 4,966,163 describes yet another kind of extendable guidewire
assembly. In this assembly one of the wires carries an internally
threaded sleeve and the other wire carries a threaded head. The two
wires are coupled together by threading the head into the
sleeve.
U.S. patent application Ser. No. 688,9I5, filed 19 April 1991,
describes an extendable guidewire assembly in which the ends of the
guidewire and extension wire carry axial interlocking members and
the extension wire carries a retractable sleeve which encloses the
interlocked members.
Applicant is also aware of an extendable guidewire assembly design
in which one of the wires carries an open-ended sleeve and the
other wire has a tapered tip encircled by a helical coil. The wires
are coupled by inserting the tip into the sleeve and twisting it.
The twisting causes the coil to expand and form a friction fit with
the interior of the sleeve. The wires are uncoupled by twisting the
tapered tip wire in the reverse direction.
A primary object of the present invention is to provide an
extendable guidewire assembly that may be connected and
disconnected and is relatively simple to manufacture.
DISCLOSURE OF THE INVENTION
The invention is an extendable guidewire assembly for use within a
patient's vasculature comprising in combination:
(a) a guidewire having a distal end that is adapted to be fed into
said vasculature and a tapered proximal end;
(b) an extension wire having a proximal end and a tapered distal
end; and
(c) a polymeric sleeve having first and second ends and a lumen
extending therebetween, said first end being fixedly attached
concentrically about one of either the proximal end of the
guidewire or the distal end of the extension wire such that said
one end extends partly through the lumen of the sleeve, said second
end being adapted to receive the other of the proximal end of the
guidewire or the distal end of the extension wire, said lumen
having a diameter that is smaller than the untapered diameter of
the wire to which the sleeve is not fixedly attached and wherein
the lumen expands radially when the sleeve is under axial
compression and contracts radially when the sleeve is under axial
tension.
In another embodiment, the invention also includes:
(d) a second polymeric sleeve having first and second ends and a
lumen extending therebetween, said first end having a smaller
inside diameter than said second end, said first end being
concentric about the first polymeric sleeve, said second end being
adapted to receive the proximal end of the guidewire, and to guide
the guidewire into the proximal end of the first polymeric
sleeve.
In another aspect, the invention is a kit for use in the connecting
and disconnecting of the guidewire assembly of the invention. The
kit comprises the guidewire assembly and a detachment tool, the
guidewire assembly comprising, in combination:
(a) a guidewire having a distal end that is adapted to be fed into
said vasculature and a tapered proximal end;
(b) an extension wire having a proximal end and a tapered distal
end;
(c) a first polymeric sleeve having first and second ends and a
lumen extending therebetween, said first end being fixedly attached
concentrically about one of either the proximal end of the
guidewire or the distal end of the extension wire such that said
one end extends partly through the lumen of the sleeve, said second
end being adapted to receive the other of the proximal end of the
guidewire or the distal end of the extension wire, said lumen
having a diameter that is smaller than the untapered diameter of
the wire to which the sleeve is not fixedly attached and wherein
the lumen expands radially when the sleeve is under axial
compression and contracts radially when the sleeve is under axial
tension;
(d) a second polymeric sleeve having first and second ends and a
lumen extending therebetween, said first end having a smaller
inside diameter than said second end, said first end being
concentric about the first polymeric sleeve, said second end being
adapted to receive the proximal end of the guidewire, and to guide
the guidewire into the proximal end of the first polymeric sleeve;
and
(e) a detachment tool having a slot that is dimensioned to receive
the untapered portion of the guidewire, the slot being further
dimensioned such that the outer diameter of the first polymeric
sleeve is larger than the slot.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a fragmentary elevational view of a preferred embodiment
of the extendable guidewire assembly with the guidewire and
extension wire in a disconnected configuration.
FIG. 2 is a fragmentary elevational view of the embodiment of FIG.
1 with the guidewire and extension wires in their connected
configurations.
FIG. 3 is a fragmentary elevational view of a second preferred
embodiment of the extension wire of the invention with the first
and second polymeric sleeves incorporated. The extension wire is
shown in a disconnected configuration.
FIG. 4 is a fragmentary elevational view of the embodiment of FIG.
3 with guidewire and extension wires in their connected
configuration.
FIG. 5 is a fragmentary elevational view of the embodiment of FIG.
3 with guidewire and extension wires in their connected
configuration, with the second polymeric sleeve removed.
FIG. 6 is a fragmentary elevational view of the embodiment of FIG.
3 with guidewire and extension wires in their connected
configuration, with the second polymeric sleeve removed, and with
the detachment tool in place.
Like elements in the drawings bear the same reference numeral.
MODES FOR CARRYING OUT THE INVENTION
The drawings illustrate the preferred embodiments of the extendable
guidewire assemblies of the invention. The three principal
components of the first preferred assembly are: a guidewire 11, an
extension wire 12, and a sleeve 13. In these figures only the
proximal end 14 of the guidewire and the distal end 15 of the
extension wire are shown. The remainders of the two wires are not
shown and are of conventional structure.
While this invention may be practiced with guidewires of any length
and diameter, it will typically be employed with stainless steel or
nickel-titanium alloy guidewires and extensions that are .div. 0.46
mm in diameter (untapered), more normally 0.25 to 0.40 mm in
diameter (untapered). Preferably, the diameters of the guidewire
and extension wire are the same. In most instances the length of
the guidewire will be in the range of 100-200 cm and the extension
will be on the order of 125 to 225 cm in length.
The proximal end 14 of guidewire 11 has a tapered section 16. For
manufacturing convenience the taper will normally be conical,
although other taper configurations may be used. The taper is
continuous and the length of section 16 will normally be 3 to 7 cm,
more usually 5 to 6 cm.
The distal end 15 of the extension wire 12 has a similarly tapered
section 17. It, too, is preferably conical, continuous and extends
over a length of 3 to 7 cm, usually 5 to 6 cm.
Sleeve 13 preferably has an outer diameter that is equal to or less
than the outer diameters of the untapered portions of the guidewire
and extension wire. Correspondingly, the diameter of its lumen 18
will be less than the individual diameters (untapered) of the two
wires. The lumen diameter will typically be 0.2 to 0.36 mm, more
usually 0.25 to 0.30 mm. In the embodiment shown in the drawing the
sleeve is attached to the tapered end of the extension wire by
means of an adhesive 19. Because the diameter of the lumen 18 is
smaller than the untapered diameter of the extension wire, the site
of affixation is on the tapered portion.
The length of tubular sleeve 13 is such that the tapered portion 17
of the extension wire extends within the lumen over half the length
of the sleeve. As shown in the drawing, when the wires are
connected the tapered end of the guidewire also extends into the
lumen over half the length of the sleeve. Thus, the tapered tips of
the wires axially overlap within the lumen. With wires of the
dimensions given above, the length of the sleeve will usually be 5
to 8 cm, more usually 6 to 7.5 cm.
The tube is made of a polymer that will provide a friction fit
between the contact surface between its inner wall and the tapered
section 16 of the guidewire. Further, the nature of the mechanical
properties of the polymer and the wall thickness of the sleeve are
such that the sleeve will act as a "Chinese finger tube" and its
lumen will expand when the sleeve is under axial compression and
contract when the sleeve is under axial tension. In this regard the
wall thickness of the sleeve will usually be 0.025 to 0.05 mm and
the sleeve will be made of polyimide or other polymer of like
mechanical properties.
The guidewire and extension wire are connected by simply inserting
the tapered end of the guidewire into the sleeve until a tight
friction fit between the sleeve and the tapered end of the
guidewire is achieved. (See FIG. 2.) Locking of the connection
between the wires may be verified by applying axial tension to both
wires close to the sleeve junction. Because of the "Chinese finger
tube" fit, the wires can be disconnected only by placing force on
(gripping) the distal end face 20 of the sleeve, and pulling the
tapered end of the guidewire from the lumen. Any manipulation that
places the sleeve under axial tension contracts the lumen and
exerts radial force at the contact surfaces of the sleeve and the
tapered portion of the guidewire.
In a second embodiment, the extension wire is directed into the
first polymeric sleeve 13 by means of a second polymeric sleeve,
introducer 21 (See FIGS. 3 and 4). The introducer comprises a
polymeric material wherein the proximal end 23 is generally
concentric about the first polymeric sleeve 13 described above. The
distal end 25 of the introducer 21 has a greater inside diameter
than the proximal end 23 such that the guidewire 11 is easily
inserted into the introducer (FIG. 4). The introducer contains a
tapered section 27 that directs the wire into the first polymeric
sleeve 13. When the guidewire 11 is securely in place inside the
first polymeric sleeve 13, the introducer is removed (FIG. 5). In
the embodiment shown in FIGS. 3 and 4 the introducer has a slit
along the entire length of its proximal 23 and distal 25 segments.
Following insertion of the proximal end 14 of guidewire 11, the
introducer 21 is peeled away by grasping tab 29 and pulling. The
slit in the introducer is thereby opened and the introducer can
easily be pulled off of the extension wire and guidewire
assembly.
The proximal end 23 of introducer 21 preferably has an inner
diameter that is smaller than the outer diameter of sleeve 13. The
inner diameter of proximal end 23 will typically be 0.22 to 0.46
mm, more usually 0.28 to 0.30 mm. The distal end 25 of the
introducer 21 preferably has an inner diameter that is large enough
for easy insertion of the guidewire 11. The inner diameter will
typically be 0.5 to 3.0 mm, more usually 0.6 to 1.4 mm. The length
of the introducer is such that the sleeve 13 extends within the
lumen of the introducer 21 over half the length of the first
polymeric sleeve 13. As shown in the drawings, when the wires are
connected, the tapered end of the guidewire also extends into the
lumen over half the length of the introducer. With wires of the
dimensions given above, the length of the introducer will usually
be 3 to 10 cm, more usually 3.5 to 5 cm.
The introducer 21 is made of polymeric tubing. The material is such
that it has the mechanical strength to withstand the insertion of
the guidewire, but can be easily peeled away when the insertion is
complete. In this regard, the wall thickness of the introducer will
usually be 0.10 to 0.13 mm and the introducer will be made of 1 to
5 mm outer diameter polyethylene tubing. The introducer may also be
made of tubing of other polymers of like mechanical properties.
An extendable guidewire assembly according to the invention was
made as follows. Using a centerless grinder, the proximal end of a
195 cm long stainless steel catheter guidewire having a 0.014" OD
was ground to 0.002" tip OD with a 6.0 cm taper length. The end of
a different wire of the same diameter, about 160 cm long, was
ground similarly as the guidewire. This wire served as the
extension wire. Polyimide tubing (purchased from H.V. Technology)
with a 0.013" OD and a 0.00I" wall thickness was cut squarely to
about 7.5 cm long. A thin film of epoxy adhesive was applied on the
ground segment of the extension wire. The tip of the extension wire
was inserted into the polyimide tubing and pressed until the wire
locked. The epoxy was allowed to cure overnight. Alternatively the
epoxy may be cured by heating for 3 min at .apprxeq. 135.degree. C.
Extension of the guidewire was accomplished by inserting the ground
proximal end of the guidewire into the polyimide tube of the
extension wire. The catheter wire was pressed firmly into the
tubing.
Where the extension wire and guidewire assembly included an
introducer, the introducer was formed from polyethylene tubing
according to the following procedure.
A 7.5 cm length of tubing with an outer diameter of 2 mm was cut.
Heat was applied to the proximal end 23 of the tubing in order to
form a section that is 4 cm long and has an inner diameter of about
0.30 mm. The tab 29 was similarly formed by heat shrinking the
section of tubing that comprises the tab until the tubing had an
outer diameter of about 0.89 mm and was about 1 cm long.
In order that the introducer be removable after the guidewire has
been inserted, a slit was cut the length of the introducer. The
introducer was slid into place over the first polymeric sleeve 13
and shrunk fit over the first polymeric sleeve to secure it in
place. An opening dimensioned 2 by 4 mm was cut in the distal end
25 of the introducer 21 such that the proximal end 14 of guidewire
11 could easily be inserted into the introducer.
In another aspect, the invention comprises a kit for the connecting
and disconnecting of the extension wire from the guidewire
assembly. The kit contains the guidewire assembly with peel away
introducer described above. The kit further contains a detachment
tool 31. The tool is shown in FIG. 6 and has a slot 33 dimensioned
to receive the guidewire, that is, it is larger than the outer
diameter of the untapered portion of the guidewire but smaller than
the outer diameter of the first polymeric sleeve.
The tool may be any convenient shape that can be easily handled and
is made of a metal or polymer of sufficient mechanical strength for
putting tension on the first polymeric sleeve as described below.
The slot may be in any convenient shape but will typically be a
rectangular opening that is 0.30 to 0.40 mm by 5 to 10 mm, more
usually 0.30 to 0.35 mm by 5 to 6 mm.
The guidewire and extension wire assembly of the kit are connected
and disconnected as described above. The introducer is peeled away
prior to use of the assembly in the vasculature. In order to
disconnect the guidewire and extension wire, the detachment tool is
placed about the guidewire at the proximal end of the first
polymeric sleeve. The tool is then pulled in the direction of the
proximal end of the extension wire such that the first polymeric
sleeve is compressed. In this way, the radial force exerted by the
sleeve is released and the extension wire can easily be removed by
pulling it out of the sleeve.
While the above-described embodiments show the first and second
polymeric sleeves affixed to the extension wire, it will be
appreciated that the respective wire structures may be reversed
(i.e., the sleeves are affixed to the proximal end of the
guidewire). Similarly, other modifications of the above-described
embodiment of the invention that are obvious to those of skill in
the mechanical and guidewire/catheter arts are intended to be
within the scope of the following claims.
* * * * *